Kornimate/medical-research-clean huggingface dataset:
natural history and outcomes in x-linked hypohidrotic ectodermal dysplasia

Conditions: X-Linked Hypohidrotic Ectodermal Dysplasia

Summary: the proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of xlhed based on genetic testing and who have not received an investigational study drug. the study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs.

important to the development and regulatory approval of therapies for xlhed will be the collection of data on the clinical history and prospective health of those affected by xlhed. the proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of xlhed based on genetic testing and who have not received an investigational study drug. the study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs. genotype-phenotype correlations in xlhed, based on well-documented health records and prospective assessments on genetically-confirmed individuals, may now provide new and clinically-predictive information for the benefit of patients, families, health care providers and clinical investigators designing trials for therapeutic interventions.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria to be enrolled in this study: 1. confirmed genetic diagnosis of xlhed 2. written informed consent of both parents (if reasonably available) exclusion criteria: subjects who meet any of the following criteria cannot be enrolled in this study: 1. medically-significant complications or congenital anomalies outside of those considered to be associated with the diagnosis or status of xlhed 2. having received an investigational study drug prior to enrollment. for subjects less than 6 months of age, the mother cannot have taken an investigational drug during her pregnancy. 3. known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists 4. presence of pacemakers

Keywords: x-linked hypohidrotic ectodermal dysplasia xlhed hypohidrotic ectodermal dysplasia hed christ-siemens-touraine syndrome
intraoperative use of the bp device for detecting positive margins during lumpectomy procedure

Conditions: Breast Cancer

Summary: this protocol was designed for testing the intraoperative use of the dune device. this multicenter study will take place in israel at 12 sites.

use of the device will take place during a partial mastectomy procedure (lumpectomy).the patient will be randomized to enter the device or control arm.

Eligibility criteria:
inclusion criteria 1. women diagnosed with carcinoma of the breast 2. undergoing lumpectomy (local wide excision) procedure. 3. over 18 years of age 4. signed icf exclusion criteria 1. neoadjuvant systemic therapy 2. previous radiation in the operated breast 3. prior surgical procedure in the same quadrant 4. implants in the operated breast 5. pregnancy 6. participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Keywords: idc dcis ilc
deep brain stimulation for traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the study will evaluate the benefit of deep brain stimulation for subjects with severe disability due to traumatic brain injury.

the study will evaluate the benefit of deep brain stimulation for subjects with severe disability due to traumatic brain injury. dbs has been proven safe and efficacious for remediation of multiple neurological conditions. it is the hope of the study team that the protocol will provide further insight into the potential of dbs to improve the quality of life and functioning of persons with severe disability due to tbi and at the same time can provide new clinical insights that will improve treatment for the entire spectrum of injury severity.

Eligibility criteria:
inclusion criteria: * 24 months post traumatic brain injury scores in severe range of the glasgow outcome scale-extended evidence of impaired cognitive functioning medically and neurologically stable exclusion criteria: * medical contraindications for surgery evidence of substance abuse in the last 12 months current diagnosis of major depressive disorder current participation in rehabilitation services co-morbid conditions that would interfere with study activities

Keywords: traumatic brain injury dbs
prospective evaluation of the clinical utility of endoscopically placed self-expandable stents

Conditions: Gastrointestinal Diseases

Summary: the investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. the purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. scheduled to undergo endoscopy with placement of self-expanding stent at the university of florida, gainesville, fl. 3. subject must be able to give informed consent. exclusion criteria: 1. any contraindication to performing endoscopy. 2. participation in another research protocol that could interfere or influence the outcomes measures of the present study. 3. the subject is unable/unwilling to give informed consent.

Keywords: any gastrointestinal problem that would require an endoscopically placed stent
targeting stress-induced alcohol relapse risk with doxazosin xl

Conditions: Alcohol Use Disorder

Summary: participants (n=10/group) will consist of non-treatment seeking individuals with aud. following informed consent and baseline screening, participants will partake in 3 stress induction sessions to assess their stress levels and cravings for alcohol. participants will be randomized to receive either increasing doses of doxazosin xl (0, 4, and 8 mg) or placebo in a double-blind manner.


Eligibility criteria:
inclusion criteria: * meet dsm-5 criteria for aud; * report excessive alcohol use as defined by cdc guidelines in the past month (\>7 drinks/week for woman, \>14 drinks/week for men, \>3 drinks/occasion for women\>4 drinks/occasion for men)3. exclusion criteria: * physical dependence on alcohol assessed using the scid and clinical institute withdrawal assessment for alcohol (ciwaa)41. * presenting an alcohol use disorders inventory (audit) score indicative of severe alcohol dependence (≥13 for women, ≥15 for men); * meeting criteria for substance use disorder on drugs other than alcohol and nicotine; * currently taking a prescribed psychoactive medication (e.g., atomoxetine for adhd). in addition, exclusion for those individuals taking cyp3a4 inhibitors. most participants will not be taking any concomitant medications (including over-the-counter supplements). for those who are taking an allowed medication, the study physician will determine if the medications are cyp3a4 inhibitors. * medical conditions contraindicating doxazosin xl pharmacotherapy (e.g., postural hypotension); * taking contraindicated medications such as blood pressure medications; * be pregnant, nursing, or planning on becoming pregnant during the course of the study; * have any other illness, condition, or use of medications, which in the opinion of the pi and/or admitting physician would preclude safe and/or successful completion of the study.
non-contrast dwi for supplemental screening

Conditions: Breast Cancer

Summary: diffusion-weighted imaging (dwi) is a short (under 5 minutes) non-contrast mri technique that has shown promise for the detection and characterization of breast cancer. our preliminary data has shown that dwi holds potential for detecting mammographically and clinically-occult breast cancers. however, current technical limitations reduce the sensitivity of dwi for screening applications. the identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced mri would have significant clinical impact by improving the early detection of cancer in women with dense breasts. we hypothesize that an optimized dwi approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

hypothesis: with technical optimizations, non-contrast dwi can detect clinically and mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate. aim 1: improve the breast dwi technique to maximize spatial resolution, reduce distortion, and increase lesion contrast. * develop novel dwi acquisition to increase spatial resolution and reduce distortion (using reduced field of-view and/or multishot echo planar imaging techniques) * identify optimal diffusion sensitization (b-value) to maximize conspicuity of cancers in women with dense breasts aim 2: develop interpretation tools to optimize diagnostic performance for detecting cancer on dwi. * determine quantitative dwi thresholds (contrast-to-noise ratio, apparent diffusion coefficient \[adc\]) that best differentiate benign and malignant lesions (i.e. maximize sensitivity and specificity) * develop computer aided assessment tools to facilitate clinical implementation and optimize reader accuracy aim 3: test the performance of the optimized dwi approach for detecting clinically and mammographically-occult cancer in women with dense breasts. * conduct a controlled reader study of non-contrast dwi alone for breast cancer detection * perform receiver operating characteristic (roc) analysis and determine the sensitivity and specificity for detection of mammographically occult cancer

Eligibility criteria:
inclusion criteria: 1. women aged 18 or older 2. dense breast identified on mammogram exclusion criteria: 1. contra-indication to contrast-enhanced breast mri (e.g. renal insufficiency with gfr\<60, contrast allergy, incompatible metal) 2. patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators) 3. women who are pregnant

Keywords: supplemental screening dense breasts diffusion weighted imaging
safety and effectiveness study of the vega uv-a system for cross-linking in eyes with keratoconus and ectasia

Conditions: Keratoconus and Ectasia

Summary: the purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.


Eligibility criteria:
inclusion criteria: * 12 years of age or older * diagnosis of keratoconus or ectasia * central or inferior steepening on the pentacam map * topography consistent with keratoconus or ectasia * bscva 20/20 or worse * removal of contact lenses for required period of time * signed written informed consent * willingness and ability to comply with schedule for follow up visits exclusion criteria * for keratoconus, a history of previous corneal surgery * corneal pachymentry equal to or greater and 400 * previous ocular condition in the eyes to be treated that may predispose the eye for future complications * a history of chemical injury or delayed healing * pregnancy * a known sensitivity to the study medications * nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests * presence or history of any other condition or finding that makes the patient unsuitable as a candidate
a single-center, clinical study to evaluate the safety of a new personal lubricant in healthy female subjects

Conditions: Erythema; Edema

Summary: to evaluate the safety of a new personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.


Eligibility criteria:
inclusion criteria: * no participation in a similar study 2-weeks prior * may be post-menopausal or have had a hysterectomy * if sexually active, and of child bearing potential, subjects using adequate non-barrier method of birth control * free from any vaginal disorders * sexually active and monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active * personal lubricant user and agrees to replace her usual personal lubricant with the investigational product * can start regardless of where they are in their cycles * agrees to use the provided investigational product at least four times weekly over the two week study period * exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam * willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study * agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area * willing to use a urine pregnancy test provided to them at baseline and on third visit * standard medical history form on file * signed informed consent * completed hipaa * dependable and able to follow directions as outlined * receives a score of 0 or 0.5 for erythema and edema: and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination. exclusion criteria: * pregnant, nursing or planning a pregnancy * currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines * known allergies to vaginal or any cosmetic products * reports history of recurrent bladder, vaginal infections or incontinence * exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation * uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception * participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation * receives a score higher than 0/5 for erythema, edema or \>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
ct and clinical features of internal hernia

Conditions: CT Images of Internal Hernia; Clinical Outcomes

Summary: researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between feb. 2012 and feb. 2018. and analysis the medical records and mdct images to investigate the clinical and radiological features of internal hernia.

51 patients with definite diagnosis of ih during surgical exploration from feb. 2012 to feb. 2018 in our hospital were included in this research. medical records including mdct images and intra-operative findings were collected retrospectively. the ct features of different subgroups were also evaluated.

Eligibility criteria:
inclusion criteria: * ih confirmed by surgical exploration exclusion criteria: * diaphragmatic hernia and traumatic ih
comparison of intubation duration between rapid sequence intubation (rsi) technique and non-rsi technique

Conditions: Tracheal Intubation Morbidity

Summary: the purpose of this study is to evaluate intubation duration between rapid sequence intubation technique (rsi) and non-rapid sequence intubation technique (non-rsi) performed by emergency medicine residents in siriraj hospital.

a prospective cohort study was conducted in the non-traumatic emergency department (ed).

Eligibility criteria:
inclusion criteria: * patients required airway control by tracheal intubation exclusion criteria: * cardiac arrest
use of acupuncture in emergency departement

Conditions: Age ≥18 Years; Presigned Consentement to Participate in the Study

Summary: pain is the most common reason that patients present to an emergency department (ed) and is often inadequately managed. evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ed. in 1998, a united states national institute of health consensus conference panel reviewed the status of acupuncture and concluded that: "there is sufficient evidence of acupuncture's value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." similarly, in 2002, the world health organisation (who) stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness as analgesia has been established in controlled clinical studies. notwithstanding these difficulties, it has been shown that acupuncture analgesia in the treatment of chronic pain is comparable to morphine and that its better safety profile and lack of dependence makes it the preferred method of choice for these conditions. there are very few clinical trials of acupuncture for acute pain to inform clinical practice; that's why we have the idea to do this study in our emergency department.

the objective is to evaluate the efficacy and the tolerance of acupuncture compared to intravenous morphine in the management of acute pain. the results will also identify the impact that acupuncture treatment may have upon health resource utilization in the ed setting. it is a randomized, prospective, controlled, conducted into emergency department. acupuncture will be applied according to standards for reporting interventions in clinical trials of acupuncture (stricta). in all included we recorded at baseline : age, sex, job, comorbidity, hour of beginning of pain. injury nature and severity assessed by the injury severity score (iss) mechanism of the injury and radiologic findings. vaps : 0-100%

Eligibility criteria:
inclusion criteria: * traumatic and non traumatic acute (\ 40 (on a scale 0-100) * age ≥18 years * presigned consentement to participate in the study. * no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity); shoulder and elbow tendonitis; upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit; acute abdominal pain with no urgent surgical intervention including renal colic and dysmenorrhea; and acute headache . exclusion criteria: * temperature \> 37.7° c, * anticoagulation medication use or the presence of a mechanical heart valve, * skin infections that would preclude certain acupuncture points being used, * refusal, inability to consent or communication difficulties, * acute major trauma, * any form of analgesia up to 60 minutes prior to study start, * an initial pain score ≤ 40 on the pain scale (score range 0-100), * opiate contraindication, * pregnancy, * presentation to the ed \> 4 times in the previous 3 months with the same condition.

Keywords: emergency departement acute pain acupuncture morphine
osteopathic manipulative treatment for back pain

Conditions: Back Pain; Lumbar Pain; Thoracic Pain; Somatic Dysfunction; Fascial Distortion

Summary: this study will investigate if osteopathic manipulative treatment (omt) is beneficial for patients presenting with back pain.

low back pain is the most common cause of disability in people under age 45 and accounts for 20% of all physician visits. osteopathic manual treatment (omt) has been used to manage patients with acute and chronic back pain. these treatments are often reported as beneficial by patients. this study will examine the effect on functional status, range of motion, quality of life, and pain with osteopathic manipulative treatment (omt). baseline will be defined as someone who has never had omt, chiropractic, or massage, or has not received such treatments in the last 90 days. back pain will be specific to pain presenting in the lumbar or thoracic regions of the spine.

Eligibility criteria:
inclusion criteria: * adult 18 years of age or older * back pain * able to arrange transportation and arrive to three study appointments. exclusion criteria: * may not have had manual treatment (massage, chiropractic, or omt) in the last 90 days * may not have any labs or imaging for their back pain recommended by their physicians the subject has not yet completed * may not have had back surgery in past 60 days * may not be pregnant or have given birth in the last 30 days * may not have be unable to tell a member of the study team their name, city they live in and the current year.

Keywords: osteopathic manipulative treatment
trial of pemetrexed and carboplatin in patients with recurrent ovarian or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cancer

Summary: the purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. this study also includes patients with primary peritoneal cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of ovarian or primary peritoneal cancer confirmed by pathology * patients must have recurrent ovarian cancer which is sensitive to platinum therapy * prior radiation therapy is allowed measurable disease as defined by the response evaluation criteria in solid tumors (recist) guidelines, or non-measurable but cancer antigen 125 (ca-125) greater than or equal to 2x upper limit. exclusion criteria: * more than 2 lines of therapy for ovarian or primary peritoneal cancer. * pregnant or breast feeding. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.